Early Feeds in Gastroschisis

Not Applicable

Recruiting

• Conditions: Gastroschisis

• Registration Number: NCT06878950
• Lead Sponsor: University of California, Davis

Brief Summary

This study aims to evaluate the feasibility of initiating early feeds in neonates with gastroschisis, a condition where infants are born with their intestines outside the body.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-24
• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Primary Completion: 2028-02-01
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Neonates with presumed simple gastroschisis
• Born at ≥ 34 weeks' gestation
• Hemodynamically stable
• Consented within 48 hours after abdominal closure
• Mothers who are ≥16 years old
• Mothers who speak English or Spanish

Exclusion Criteria

• Neonates with evidence of complex gastroschisis at time of closure (any ischemic bowel, intestinal perforation, or obvious atresia with mesenteric defect)
• Presence of any major congenital anomalies
• Neonates who are receiving ionotropic medications
• Neonates who are wards of the state
• Neonates whose care is considered to be futile or those undergoing re-direction of care
• Neonates participating in another interventional trial
• Any patient deemed unfit for participation by study investigator(s)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of Enrollment in Early Feeding Study Cohort	From prenatal period within the first 24 hours of abdominal closure	Proportion of eligible neonates with gastroschisis whose parents/guardians consent to enrollment in the study.

Secondary Outcome Measures

Name	Time	Method
Feasibility of Protocol Adherence	From abdominal closure to 48 hours after closure.	Proportion of enrolled neonates who are initiated on introductory feeds within 48 hours of abdominal closure.
Fidelity to Protocol	From abdominal closure through discharge from the hospital, average of 90 days	Proportion of enrolled infants with gastroschisis who adhere to the remainder of the protocol without major deviations. Feasibility will be assessed using protocol adherence tracking forms completed by study team.
Protocol Withdrawal Rate	From time of enrollment (prenatal) to hospital discharge, an average of 90 days	Proportion of enrolled infants who withdraw from the study

Trial Locations

Locations (2)

UC Davis Children's Hospital; 🇺🇸 Sacramento, California, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States